A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Treatment-emergent Adverse Events
研究概览
简要总结
This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo.
详细描述
The objective of this protocol is to examine the efficacy and safety of varenicline for smoking cessation in adolescents. The guiding design philosophy was to model the adult smoking cessation literature (allowing for indirect comparisons of efficacy in different populations) while fine-tuning some elements specifically geared for adolescents. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo. Participants will provide smoking self-report (cigarettes per day) throughout the study. Biological confirmation with carbon monoxide breathalyzer will occur at all visits, and urine cotinine measurement will occur at key time points (baseline, end of treatment and final post-treatment follow-up). Psychiatric/medical visits will occur weekly throughout active treatment to systematically monitor safety and tolerability. After the 12-week treatment course, participants will return for 3 post-treatment follow-up visits (Week 13, Week 18, and Week 26).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14-21
- •Daily smoker for ≥6 months
- •Desire to quit smoking, with at least one prior failed quit attempt and willingness to participate in a treatment study
- •If under age 18, parent(s) or guardian(s) able to participate in informed consent and initial assessment (unless the participant provides evidence of emancipated status)
- •If female, agreement to use birth control (any form of hormonal contraception such as Depo-Provera, daily oral contraception, transdermal patch, or Nuva-ring; intrauterine device; sterilization; or double barrier contraception, which is a combination of any two of the following methods: condoms, spermicide, diaphragm) to avoid pregnancy
排除标准
- •Lifetime history of any DSM-IV-TR mood or psychotic disorder (e.g., major depressive disorder, bipolar disorder, schizophrenia)
- •Lifetime history of suicidality, homicidality, or clinically significant hostility/aggression
- •Current substance dependence, other than nicotine
- •Current unstable major medical disorder
- •Current pregnancy or breastfeeding
- •Current use of medications with smoking cessation efficacy
- •Known hypersensitivity to varenicline
研究组 & 干预措施
varenicline
Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.
干预措施: Varenicline (Drug)
placebo
Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Number of Participants Experiencing Treatment-emergent Adverse Events
时间窗: 26 weeks (12 weeks of treatment plus full post-treatment follow-up)
Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment.
Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment
时间窗: 7 days at end of treatment
Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit
次要结局
- Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment(12 weeks of active treatment)
- Percentage of Post-treatment Visits With Abstinence(One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits)
- Percentage of Visits With Abstinence During Treatment(12 weeks (all of active treatment))
研究者
Kevin Gray, MD
Associate Professor
Medical University of South Carolina